MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-07-03 for DYNESYS TL, SET SCREW N/A 01.03810.006 manufactured by Zimmer Gmbh.
[112995178]
Concomitant medical products: item: dynesys lis, stabilizing cord, 200, catalog #: 01. 03711. 200, lot #: 2751522; item: dynesys tl, ha pedicle screw, cannulated + set screw, 6. 0x35, catalog #: 01. 03956. 035, lot #: unk. Item: unknown dynesys set screw spine impl. Catalog #: unk. Lot #: unk. Item: dynesys tl, ha pedicle screw, cannulated + set screw, 7. 2x50, catalog #: 01. 03957. 250, lot #: 2701342. The device will not be returned for analysis; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental medwatch 3500a will be submitted. The manufacturer did not receive x-rays, or other source documents for review. The dhr check could not be performed for all parts as not all lot numbers are available. For the parts reported with lot number the device manufacturing quality records indicate that the released components met all requirements to perform as intended. An e-mail requesting additional information was sent on june 28, 2018 to the appropriate representatives. A cause for this specific event cannot be ascertained from the information provided. As soon as supplemental information becomes available an updated report will be submitted. (b)(4). Note: the same patient underwent a previous surgery reported in (b)(4). The following reports are associated with this event: 0009613350 - 2018 - 00668, 0009613350 - 2018 - 00670, 0009613350 - 2018 - 00671, 0009613350 - 2018 - 00672.
Patient Sequence No: 1, Text Type: N, H10
[112995179]
It was reported that a patient was initially implanted with dynesys implants and underwent second revision due to over correction approximately five years post implantation. The surgeon confirms, that no hardware was removed during second revision, but additional screws were placed. Note: the dynesys products remain implanted. Hence, no explantation date is captured.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0009613350-2018-00669 |
| MDR Report Key | 7657683 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-07-03 |
| Date of Report | 2018-11-22 |
| Date of Event | 2018-06-01 |
| Date Mfgr Received | 2018-11-19 |
| Device Manufacturer Date | 2013-03-08 |
| Date Added to Maude | 2018-07-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DR. |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| Manufacturer G1 | ZIMMER GMBH |
| Manufacturer Street | SULZER ALLEE 8 SULZER INDUSTRIE PARK |
| Manufacturer City | WINTERTHUR 8404 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 8404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DYNESYS TL, SET SCREW |
| Generic Name | DYNESYS TOP-LOADING SPINAL SYSTEM |
| Product Code | NQP |
| Date Received | 2018-07-03 |
| Model Number | N/A |
| Catalog Number | 01.03810.006 |
| Lot Number | 2699345 |
| ID Number | 00889024481176 |
| Device Expiration Date | 2018-02-28 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER GMBH |
| Manufacturer Address | SULZER ALLEE 8 SULZER INDUSTRIE PARK WINTERTHUR 8404 SZ 8404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2018-07-03 |